Associate Regulatory Affairs Specialist
About The Position
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life The Cardiac Rhythm Management operating group is a division within Medtronic focused on developing and manufacturing medical devices and solutions for the management of cardiac arrhythmias and heart failure. This group’s product portfolio includes implantable pacemakers, implantable cardioverter-defibrillators (ICDs), cardiac resynchronization therapy (CRT) devices, and remote monitoring systems. CRM’s mission is to improve patient outcomes and quality of life by providing innovative therapies for the detection, prevention, and treatment of abnormal heart rhythms. The group collaborates closely with healthcare professionals and leverages advanced technology and data-driven insights to drive improvements in cardiac care. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This position will be based in Mounds View, MN. The Associate Regulatory Affairs Specialist is responsible for collaborating, planning and executing regulatory activities related to Class II and Class III Cardiac devices and therapies to markets for the US FDA and EU Notified Bodies. You will be assessing the regulatory impact of post-market changes to cleared & approved products and processes and coordinate the implementation of any resulting regulatory strategy for the worldwide market. You will also be coordinating with our regulatory partners worldwide for new device registrations, renewals, and tenders for OUS markets.
Requirements
- Bachelor's Degree
- 0 regulatory affairs experience
Nice To Haves
- Bachelor’s Degree in a health profession, science and/or engineering field
- Experience in medical device industry
- Demonstrated technical writing skills
- Strong computer skills, including word processing, spreadsheets and slide presentations
- Excellent organizational, project management skills
- Strong written, verbal and interpersonal skills
- Notary license
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Responsibilities
- Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
- Leads or compiles all materials required in submissions, license renewal and annual registrations.
- Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
- Monitors and improves tracking / control systems.
- Keeps abreast of regulatory procedures and changes.
- May direct interaction with regulatory agencies on defined matters.
- Recommends strategies for earliest possible approvals of clinical trials applications.
Benefits
- Medtronic offers a competitive Salary and flexible Benefits Package
- A commitment to our employees lives at the core of our values.
- We recognize their contributions.
- They share in the success they help to create.
- We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
